Mobile Application in the Management of Mild to Moderate Postpartum Depression (PPD)
Status unconfirmed · Not applicable
Conditions studied: Post-partum Depression
In brief
Primary Objective: Evaluate the user experience with the Stella (TM) app for the management of Postpartum Depression in an observed population for 8 calendar weeks.
Key facts
- Study ID
- NCT05077644
- Run by
- Curio Digital Therapeutics, Inc.
- People needed
- 65
- Starts
- 2021-10-01
- Expected to finish
- 2021-12-31
- Last updated by the study team
- 2021-10-14
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Participants residing in the states of New York, New Jersey or Connecticut and must be able to read, write, and speak English, and provide written informed consent prior to enrollment
- Participants must be between 18 and 50 years of age
- Participants must have given live birth within the 4 months prior to the start of study
- Participants diagnosed with mild to moderate postpartum depression (as assessed by a clinician upon enrollment) and have scored between 9 and 21 on the Edinburgh Postnatal Depression Scale (EPDS) during screening
- Participants must answer "0/Never" or "1/Hardly Ever" to the self-harm question on EPDS (Question #10)
- Participants must be willing to use a mobile app and own an iOS enabled mobile phone
- Participants must have wireless internet connectivity in the home and be willing to connect devices to their home Wi-Fi network.
You may not qualify if…
- Participants who do not reside in the states of New York, New Jersey or Connecticut
- Participants who are not able to read, write, and speak English, and provide written informed consent prior to enrollment
- Participants less than 18 and more than 50 years of age
- Participants who have not given birth within the 4 months prior to the start of study OR did not have a live birth in the last 4 months
- Participants who have not been diagnosed with postpartum depression upon clinical assessment OR do not have a score of between 9 and 21 on the EPDS
- Participants with a positive (2 or 3) answer on the EPDS self-harm question (Question #10)
- Participants with Serious Mental Illnesses (SMIs), severe depression, or cognitive impairments
Where it is running
- HITLAB — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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